FDA places a clinical hold on a KalVista Pharmaceuticals proposed Phase 2 clinical trial of KVD824 for preventing hereditary angioedema attacks.
FDA says a Medtronic recall of 93 units of its Bio-Console 560 blood pumping console due to potential electrical failure is Class 1.
FDA releases summaries of two PDUFA 7 negotiating sessions by the FDA/industry pre-market subgroup.
FDA releases its latest batch of Warning Letters that includes one medical product company Hou Fu Biotech.
FDA clears a Zimmer Biomet 510(k) for the Rosa Partial Knee System for robotically-assisted partial knee replacement surgeries.
AdvaMed says FDA should apply the same policies to software in a medical device that it applies to software as a medical device.
FDA releases a summary of discussions on seven topics at the second MDUFA 5 reauthorization negotiation meeting.
A bipartisan group of House members introduces legislation to end mandatory animal testing in drug development.